> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-52/
- Published: 2021-08-29T12:00:00.000Z
- Updated: 2026-09-14T17:12:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150041

**Breckenridge’s Solifenacin Succinate ANDA Withdrawn**  
8/27/2021 *Federal Register* notice: FDA has withdrawn the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg and 10mg) after the company requested such action. The company’s request is related to a 1/23/2020 field alert report that indicated the tablets may convert to solifenacin tartrate during manufacturing due to an interaction between solifenacin succinate and tartartic acid, which is an inactive ingredient in this drug product’s formulation. On 1/24/2020, Breckenridge issued a Class recall related to the matter. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-18586.pdf?ref=fdaweb.com).

**CDER Promotional eSubmission Validation Errors**  
8/27/2021 *Federal Register* notice: CDER has announced that 10/18 is the effective date that it will begin rejecting submissions that fail either Electronic Common Technical Document (eCTD) validation 1551 or 1553, which are high severity validation errors. The validation is related to certain types of promotional material-related submissions, including postmarketing submissions of promotional materials using Form FDA 2253\. When submitting this form, firms must include the current product labeling. Electronic Common Technical Document validations 1551 (“2253 submission does not include product labeling”) and 1553 (“The only valid FDA form to include in a 2253 submission is FDA Form 2253”) describe parts of the eCTD specifications that were not followed correctly. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-18587.pdf?ref=fdaweb.com).

**Nonprescription Drugs Panel Renewed for 2 Years**  
8/26/2021 *Federal Register* notice: FDA has announced the renewal of its Nonprescription Drugs Advisory Committee for an additional two years. The new charter will be in effect until 8/27/2023\. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-08-26/pdf/2021-18396.pdf?ref=fdaweb.com).

**Circulatory System Panel Meeting on Endovascular Grafts**  
8/26/2021 *Federal Register* notice: FDA has announced an 11/2-3 Medical Devices Advisory Committee Circulatory System Devices Panel meeting. On 11/2, panel members are scheduled to discuss and make recommendations on information about the Endologix AFX endovascular graft system’s benefit-risk profile regarding Type 3 endoleaks. On 11/3, they will offer recommendations on the continued safety and effectiveness of endovascular stent grafts, and how to strengthen real-world data collection on the devices’ long-term performance. FDA intends to request panel input on the clinical outcomes that are most relevant to capture in the real world, along with their frequency and duration. Additionally, it intends to seek input on data collection platforms, and how to incentivize and optimize real world data collection. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-08-26/pdf/2021-18403.pdf?ref=fdaweb.com).

**Panel to Vote on Integra LifeSciences’ Breast Reconstruction**  
8/25/2021 *Federal Register* notice: FDA has announced a 10/20 Medical Devices Advisory Committee General and Plastic Surgery Devices Panel meeting. Panel members are scheduled to vote on a Integra LifeSciences PMA for the SurgiMend PRS Acellular Bovine Dermal Matrix and its intended use as soft tissue support in post-mastectomy breast reconstruction. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-08-26/pdf/2021-18394.pdf?ref=fdaweb.com).

**Info Collection on Data Monitoring Committees**  
8/24/2021 *Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees” (OMB Control Number 0910-0581). The collection supports agency regulations and associated guidance requiring sponsors to monitor studies evaluating new drugs, biologics, and devices. Data monitoring committees advise the sponsor about the continuing safety of current trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-18235.pdf?ref=fdaweb.com).